Hamilton Medical Issues a Medical Device Safety Alert on certain RAPHAEL Ventilators

Date of Recall

2006-06-06

Recall Details

Reno, NV, June 6, 2006 -- Hamilton Medical, Inc. announced today that it is initiating a nationwide voluntary recall of forty seven (47) RAPHAEL ventilators with older generation software. Current RAPHAEL Color and RAPHAEL XTC ventilators are not affected by this action. Only four (4) customer facilities have been impacted by this action. Hamilton Medical, Inc. has already contacted these facilities regarding immediate field corrections.

This voluntary recall is being conducted because the RAPHAEL ventilator, under certain very specific conditions following an oxygen cell calibration without a compressed air supply, as instructed in the RAPHAEL Operator's Manual, can be put into a state where no visible or audible alarms are triggered. Hamilton Medical investigated a single complaint and found that a software algorithm designed to suppress false positive alarms may preclude any alarm under this scenario. "It should be noted," states David Costa, Vice President for Hamilton Medical, Inc., "that the oxygen cell calibration is intended to be performed while the RAPHAEL is connected to both air and oxygen high pressure gas sources. In the reported incident, this was not the case".

The following RAPHAEL ventilators are affected:

RAPHAEL (Software version 2.2x)
RAPHAEL Silver (Software version 2.2xS)
RAPHAEL Color (Software version 2.2xC, 2.2xCU)

Customers who have product affected by this recall should (1) verify the proper function of their devices as described in Section 3 of the RAPHAEL Operator's Manual, (2) attach a caution sticker to the ventilator advising the clinician to check the LowMinVol alarm after oxygen cell calibration and (3) change their in-house test procedures for oxygen calibration as indicated in the corrective action package supplied to each affected user. Copies of this information are available from the Company although each customer affected has already been contacted and this information has been forwarded. The ventilators may continue to be used after these steps are complete.

Hamilton Medical, Inc. has also arranged for all customer units affected by this action to receive new current generation software at no charge, that will not only eliminate this problem but also provide our valuable customers with noninvasive ventilation (NIV) and with tubing resistance compliance (TRC) along with a bi-directional apnea back-up among other enhancements.

Customers outside of the United States and Canada are encouraged to contact Hamilton Medical AG, Technical Support at +41 81 6606010, [email protected] for specific information related to international devices.

The RAPHAEL Ventilator is a continuous ventilator designed for ventilation of adult and pediatric patients weighing from 5 to 200 kg. The RAPHAEL ventilator is intended for use by properly trained personnel under the direct supervision of a licensed physician. The RAPHAEL ventilator is intended for use at the bedside and for transport within a hospital or hospital-type facility, provided compressed gas is supplied.

Hamilton Medical, Inc. identified the problem after an analysis of a single customer complaint. The Company has received no reports of adverse events or injuries resulting from the problem. Hamilton Medical notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily recall the product. Customers with questions may contact the Company at 800-426-6331 for a complete set of documentation relating to this action.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .

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